NDC 25208-100

PREXXARTAN

Prexxartan

PREXXARTAN is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Medicure International Inc.. The primary component is Valsartan.

• Product ID: 25208-100_7ad4ad18-919e-48fe-b630-213ead75a8b6
• NDC: 25208-100
• Product Type: Human Prescription Drug
• Proprietary Name: PREXXARTAN
• Generic Name: Prexxartan
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-01-02
• Marketing Category: NDA / NDA
• Application Number: NDA209139
• Labeler Name: Medicure International Inc.
• Substance Name: VALSARTAN
• Active Ingredient Strength: 4 mg/mL
• Pharm Classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 25208-100-08

473 mL in 1 BOTTLE (25208-100-08)

• Marketing Start Date: 2018-01-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25208-100-06 [25208010006]

PREXXARTAN SOLUTION

• Marketing Category: NDA
• Application Number: NDA209139
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-02
• Inactivation Date: 2020-01-31

NDC 25208-100-07 [25208010007]

PREXXARTAN SOLUTION

• Marketing Category: NDA
• Application Number: NDA209139
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-02
• Inactivation Date: 2020-01-31

NDC 25208-100-08 [25208010008]

PREXXARTAN SOLUTION

• Marketing Category: NDA
• Application Number: NDA209139
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-02
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
VALSARTAN	4 mg/mL

OpenFDA Data

• SPL SET ID: df73d781-65d8-4aaa-9b0f-de4341f639ec
• Manufacturer:
  • Medicure International Inc.
• UNII:
  • 80M03YXJ7I
• RxNorm Concept Unique ID - RxCUI:
  • 1996254

Pharmacological Class

• Angiotensin 2 Receptor Antagonists [MoA]
• Angiotensin 2 Receptor Blocker [EPC]